In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
The primary objective of the study is to evaluate the long-term
overall success rate (see primary
end-points for the definitions) of the investigational device as compared to the control in subjects enrolled in the pivotal IDE study of the Mobi-C (2- levels) device (IDE Number G050212).
Design-Prospective Cohort, a long term follow-up of the IDE
patients ( investigational and controls)
Study Population Description
All eligible Mobi-C patients (n=221 -randomized and n=8 - training cases) treated at two contiguous
levels All eligible fusion patients (n=99- randomized at 24-months) treated at two contiguous levels under the LDR-001 Pivotal Study (IDE G050212)
Investigational¿n=221 -randomized and n=8 -training cases at treated at two contiguous levels. Control¿ all eligible
fusion patients (n=99) treated at two contiguous levels
For Mobi-C: Pain/Disability Improvement of at least 25% in the Neck Disability Index (NDI) at
5 years and 7 years; no device failures at the index level requiring revision, re-operation, removal, or supplemental fixation; absence of major complications defined as 1) neurologic deterioration, 2) radiologic failure and 3) adverse events determined to be major complications and related to the study
For Fusion ACDF: evidence of bridging trabecular bone and <2º
total angular motion (from flexion to extension) and <50% radiolucency along the graft/endplate interface and for Mobi- C® subjects radiologic failure is defined as evidence of continuous bridging bone and <2º total angular motion.